The past year has been another busy and productive year for our breast cancer research programme. Particular highlights over the year include the first major presentations and publication from our Waikato Breast Care (Cancer) Register (WBCR); the completion of two major local projects (one evaluating a Waikato incidence of lymphoedema and the other wound infiltration with local anaesthetic after breast surgery). Waikato is the top NZ site and in the top three in Australia and NZ for accrual to our breast cancer prevention trial, IBIS II (top recruiter for the decision aid substudy). We are top site for both SNAC2 accrual, and for the LATER Trial in ANZ! Improving breast cancer care through research requires resource to employ our dedicated research staff and cover other costs. As demonstrated in our annual accounts, over 80% of funds raised is spent on our research programme and less than 20% on administration and fundraising costs. Our “family” of sponsors and supporters are vital for enabling of our research programme and the Waikato Breast Cancer Register. We very much appreciate this ongoing support by many individuals and businesses. It was therefore very fitting to celebrate with everyone at our 10th anniversary celebration last October. My especial thanks to our breast cancer research office staff and to our Trustees. Without their dedication and efforts above and beyond, our achievements would not be possible. RESEARCH RESULTS (for trials that Waikato Women participate in) 1) Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma insitu (DCIS) : long-term results from the UK/ANZ DCIS trial At a median of 12.7 years of follow-up results show that radiotherapy majorly reduced the incidence of ipsilateral invasive disease and ipsilateral ductal carcinoma insitu. Tamoxifen reduces the incidence of recurrent insitu disease and contralateral disease. Waikato was the only NZ centre for this international clinical trial 2) Presenting tumour features of Waikato women with newly diagnosed breast cancer from 2005-2008 The WBCR was established in 2005 to audit all Waikato women diagnosed with breast cancer. The primary goals are: to establish the nature of breast cancer presenting in a defined regional population; to examine inequalities in presentation and outcome; and to compare our results with national and international best practice.
From 2005-2008. 998/1008 (95%) eligible women consented for entry into the WBCR. This is makes the WBCR the most complete detailed regional register in NZ. The majority (~ 80%) were of European origin with Maori women making up approximately 15%. Of the women diagnosed with breast cancer who were within the screening age, only 54% were screen-detected cancers. Maori and Pacific Islanders were less likely to present with a screen-detected cancer. Maori and Pacific Island women, on average had larger tumours with a higher proportion node positive. They also had a higher proportion of HER2 positive tumours. As a result, more Maori and Pacific women required treatment with mastectomy and with chemotherapy, and long term these women are more likely to suffer recurrence and death from breast cancer. 3) Incidence of lymphoedema and other changes following surgery for breast cancer This local study analysed data from 193 women who had undergone axillary node dissection at Waikato Hospital. The main points of interest that came out of this research were:
Defining lymphoedema has been an interesting exercise. In this study using a 7.5% increase in any single arm measurement, 23.3% of women had lymphoedema.
Of this group, 24% had never noticed arm swelling and only 31% of these women described having quite a bit of swelling or a lot. This suggests that a 7.5% increase in any single arm circumference is too low a threshold.
Using a 10% threshold for increase in any single arm measurement, 13% of women had lymphoedema and 92% of these women had noticed at least some swelling since surgery, suggesting that this is a better threshold for defining lymphoedema.
Significant risk factors that make women more likely to develop lymphoedema were: increasing age, radiotherapy to the axilla or breast and infection on the operated side.
Measuring arm circumference is an easy and convenient procedure to identify women with lymphoedema and therapy can be started soon after with referral to the lymphoedema specialist.
Thanks to all women who took part, Shelley Cavanagh (Research Nurse) for coordinating this study and other Waikato Hospital staff who made this research happen! The study results have been presented in March at the New Zealand Association of General Surgery meeting in26-27 March, 2011; and publication is pending. Dr Muhammad Asim (Surgical Registrar), who presented this research, won first equal prize for the NZAGS Trainee Oral Award.
PUBLICATIONS (for trials which Waikato women participate in) Presenting tumour features of Waikato women with newly diagnosed breast cancer from 2005-2008 Campbell I, Ooi C, Lawrenson R, Hamilton MA, Kuper M, Round G, Lamont D, Ellis S, and Munt C. The New Zealand Medical Journal. 5 November, 2010 123 (1325) 87-88. Breast cancer treatments for Waikato women with newly diagnosed breast cancer, 2005 – 2008 Campbell I, Ooi C, Lawrenson R, Hamilton MA, Kuper M, Round G, Lamont D, Ellis S, and Munt C. The New Zealand Medical Journal. 5 November, 2010 123 (1325) 93-94. Prospective study of effects of wound infiltration with local anaesthetic agents after breast surgery. Article title: To Infiltrate or Not? Local Anaesthetic in Breast Surgery. Campbell I et al. Article to be submitted to The Breast. Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial. Viale G, Regan MM, Dell'Orto P, Mastropasqua MG, Maiorano E, Rasmussen BB, MacGrogan G, Forbes JF, Paridaens RJ, Colleoni M, Láng I, Thürlimann B, Mouridsen H, Mauriac L, Gelber RD, Price KN, Goldhirsch A, Gusterson BA, Coates AS for the BIG 1-98 Collaborative and International Breast Cancer Study Groups. Ann Oncol 2011; E-pub 18 Feb 2011.
Effect of tamoxfien and radiotherapy in women with locally excised ductal carcinoma insitu: long-term results from the UK/ANZ DCIS trial Cuzick J et al. Lancet Oncology, January 2011, 12(1) 21-29
Cognitive function in postmenopausal breast cancer patients one year after completing adjuvant endocrine therapy with letrozole and/or tamoxifen in the BIG 1-98 trial. Phillips K-A, Aldridge J, Ribi K, Sun Z, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J.Breast Cancer Res Treat 2011; 126(1):221-226.
Preventive therapy for breast cancer: a consensus statement. Cuzick J, DeCensi A, Arun B, Brown PH, Castiglione M, Dunn B, Forbes JF, Glaus A, Howell A, von Minckwitz G, Vogal V, Zwierzina H. Lancet Oncol 2011; 12:496-503.
Do aromatase inhibitors have adverse effects on cognitive function? Phillips KA, Ribi K, Fisher R. Breast Cancer Res 2011; 13(1):203.
Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. Colleoni M, Giobbie-Hurder A, Regan MM, Thürlimann B, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Láng I, Smith I, Chirgwin J, Pienkowski T, Wardley A, Price KN, Gelber RD, Coates AS, Goldhirsch A. J Clin Oncol 2011; 29(9):1117-1124. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. J Clin Oncol 2010; 28(21):3411-3415
A new pathological system for grading DCIS with improved prediction of local recurrence: results from the UKCCCR/ANZ DCIS trial. Pinder SE, Duggan C, Ellis IO, Cuzick J, Forbes JF, Bishop H, Fentiman IS, George WD, on behalf of the UK Coordinating Committee on Cancer Research (UKCCCR) Ductal Carcinoma In Situ (DCIS) Working Party. Br J Cancer 2010; 103(1):94-100.
Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial. Phillips K-A, Ribi K, Sun Z, Stephens A, Thompson A, Harvey V, Thürlimann B, Cardoso F, Pagani O, Coates AS, Goldhirsch A, Price KN, Gelber RD, Bernhard J. The Breast 2010; 19(5):388-395. Improving informed consent: Evaluating the first decision aid in a clinical trial setting (IBIS-II breast cancer prevention trial). Juraskova I, Butow P, Smith B, Seccombe M, Coates A, Boyle F, McCarthy N, Reaby L, Forbes JF. SABCS 2010; Poster 901.
Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF, on behalf of the ATAC/LATTE investigators. Lancet Oncol 2010; 11(12):1135-1141.
Safety of letrozole and tamoxifen monotherapy: updated BIG 198. Colleoni M, Giobbie-Hurder A, Smith I, Mouridsen H, Romieu G, Neven P, Rabaglio M, Price KN, Regan MM, Coates AS. EBCC 2010; 353. PRESENTATIONS (of trials/projects that Waikato women participate in)
Every Woman Event, Monday 29th November 2010, Rydges Hotel, Rotorua.
What surgical breast cancer trials are open and why have some recent trials struggled? What is planned for the future? Sentinel Node Biopsy Session of COSA, ANZBCTG, Breast SurgANZ Tripartite Meeting, Melbourne, 8 November, 2010.
Local Therapy in Systemic Therapy Trials: Time for a change? Discussant on Panel for ANZBCTG Participants Forum, Melbourne, 8 November, 2010.
Update on the SNAC2 Trial Background and Progress. SNAC2 Trialists Meeting, Melbourne, Sunday, 7 November 2010.
Presenting features of Waikato Women with newly diagnosed breast cancer from 2005-2008. I Campbell, C Ooi, R Lawrenson, M Hamilton, M Kuper, G Round, D Lamont. Biannual Research Seminar, Waikato Clinical School 13 Oct. 2010-11-12
Breast Cancer Treatments for Waikato women with newly diagnosed breast cancer. I Campbell, C Ooi, R Lawrenson, M Hamilton, M Kuper, G Round, D Lamont. Biannual Research Seminar, Waikato Clinical School 13 Oct. 2010-11-12
Breast Cancer Follow Up and Breast Cancer Screening, I Campbell – Postgraduate Medical Education Evening Meeting, Bryant Education Centre, Waikato Hospital, Thurs 19th August 2010
Australasian Society for Breast Disease, July 8-10, 2010 Auckland: i) Minisymposium: Is breast cancer being over diagnosed? A surgeon’s perspective. ii) Chair In Situ Lesions Session.
iii) Surgical guidelines and trials – Sentinel node biopsy.
Wound infiltration study: Local anaesthetic in breast surgery. I Campbell, E. Kerr, S Cavanagh, J Creighton, R French, M Ehrstrom, J Moodie, S Banerjee. Poster presentation at the Australasian Society of Breast Diseases (July, 2010; Auckland).
Waikato Breast Care Register. The first four years of data presented in two poster presentations at the Australasian Society of Breast Diseases (July, 2010; Auckland).
SNAC2 Trialists Meeting and Presentation, RACS Annual Scientific Congress,Tue 4th- 7th May 2010, Perth Australia
First results from the Waikato Breast Cancer Register
Midland Cancer Network Breast Cancer Working Group, Bryant Centre, Friday 19th March
Waikato Breast Cancer Register Presentation, NZ Breast Cancer Foundation, Parnell Auckland, Tuesday 16th March 2010, 18:00-20:00
Wound Infiltration Study: Local anaesthetic in breast surgery, I Campbell, E Kerr, S Cavanagh, J Creighton, R French, M Ehrstrom, J Moodie, S Banerjee, Bi-Annual Research Seminar – Waikato Clinical School, Thursday 18th March 2010, 1530-45
TAILORx It is a goal of researchers to be able to more accurately determine which types of breast cancer will respond to each available treatment and which cancers will not benefit. In August/September 2010 five Waikato women enrolled in an American based collaborative study called the TAILORx trial. TAILORx stands for "Trial Assigning Individualised Options for Treatment (Rx)”. The purpose of this research is to determine which women with early stage breast cancer would be more likely to benefit from chemotherapy. Standard treatment for women who are eligible for this trial includes chemotherapy and hormonal therapy. Use of a diagnostic test called the "Oncotype DX assay" - can more precisely estimate an individual woman's chances of benefit from chemotherapy in addition to hormonal treatment. This study is aimed at women where the likelihood of benefit remains uncertain. Use of the Oncotype DX assay may result in more selective use of chemotherapy for those women who are most likely to benefit from it. It may also reduce the need for chemotherapy in women who are unlikely to benefit from it.
LATTE Long-term Anastrozole versus Tamoxifen Treatment Effects). This protocol is following long term effects in women who enrolled in the original “ATAC” trial (Anastrozole and Tamoxifen Alone or in Combination).
Selective Use of Post operative Radiotherapy aftEr MastectOmy (SUPREMO). A trial assessing the role of adjuvant radiotherapy in “intermediate risk” operable breast cancer following mastectomy.
A phase 3 study of GDC-0941 or GDC-0980 with Fulvestrant versus Fulvestrant in advanced or metatstatic breast cancer in patients resistant to aromatase inhibitor therapy.
Study of Anastrozole and Radiotherapy Sequencing (STARS breast trial).
Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer.
Outcomes for Waikato Maori women diagnosed with breast cancer (a project from the WBCR data)
Post mastectomy radiotherapy outcomes (a project from the WBCR data)
A summary of the trials work to which we are currently contributing to is appended to the end of this report. THE WAIKATO BREAST CARE REGISTER (WBCR) The WBCR has been operational since January, 2005 we have now entered over 1400 cases as of June, 2011. Currently we have a consent rate exceeding 98%. In August, 2010 we were successful with a two year grant of $150,000 (2010 -2012) from the NZ Breast Cancer Foundation. With a shortfall in salary costs we are very grateful for a grant of $86,500 from the Waikato Bay of Plenty Division of the Cancer Society. In addition to the goals covered under research results above, the register team enables our Breast Surgeons to meet the audit requirements and maintain their professional membership in the Society of Breast Surgeons of Australia and New Zealand. FUNDRAISING ACTIVITIES OVER THE PAST YEAR 2011 Women’s Health Diary – 3,500 were sold with total sales of $43,500.00 T-Shirt sales 540 t-shirts sold with total sales of just under $11,000 Mother’s Day Pamper Packs – 121 sold with total sales of $3,654.00 Hamilton Pink Walk Thursday 28th October, 2010 $8000 raised. Thanks to all organisations involved – Hamilton City Council, Breast Screen Aotearoa, Sport Waikato, Women’s Cancer Support Group/Cancer Society, Waikato Treasure Chests, Waikato District Health Board. Otorohanga Pink Walk Wednesday 20th October, 2010 $1500 raised from the first Otorohanga walk organised by Joan Daniels. South Waikato Pink Walk Friday 15th October 2010 $1823 was raised in the South Waikato’s second Pink Walk around Lake Moananui in Tokoroa. The walk was organised by Sport Waikato, South Waikato Pacific Island Health Committee, the YMCA and the Raukawa Trust. Huntly Pink Walk Thursday 1st October, 2010 $836 proceeds was raised in Huntly. This is the fourth year running the walk has been organised by Colleen Earby.
Cambridge Antique Fairs Eric and Russell from Classic Promotions (based in Akaroa) have coordinated two further Cambridge Antique Fair in September 2010 and May, 2011. $500 from door proceeds was donated. Pauanui Coastal Home and Garden Tour Sunday 14th November, 2010 Thanks to Shirley Haycock, home owners, sponsors/businesses and volunteers who made this fundraising opportunity to view some stunning Pauanui properties possible. Over $8000 was raised. Waikato Patchworkers and Quilters Group Thanks to Janet Ruf and members for the donation of two beautiful quilts. These were raffled off and $2030 was raised. Thames “Go Girl” Triathlon Sunday 27th March,2011 Thanks to Lisa Stent and the Thames Gym for organising this triathlon. $1551 raised. Pam and Ross Townshend – a $10,000 personal donation was received. Gallagher Group - $25,000 donation was made. Thank you to Sir Bill Gal agher. In kind sponsors - Particular recognition needs to be given to our “in kind” as well as our financial sponsors. Often our “in kind” sponsors donate generously with such things as their time and skills, venues, services, loaning of equipment or donating of products. Fundraising plans over the next year
“Dinner with a Dame” - major fundraising dinner with performance by Dame Malvina Major and sponsored by the Gallagher Group.
Growing the Waikato Breast Cancer Trust Pink Walk to make this a major fundraiser, both by sponsorship ($10,000 already secured from Braemar Hospital) and by adding a running event to start it off.
2012 Women’s Health Diary – securing sponsorship for printing costs and improving sales
Promotion of donations through bequests.
Increasing merchandise sales over the website.
BREAST CANCER RESEARCH OFFICE STAFF Waikato Breast Care (Cancer) Register staff – In October 2010 we farewelled Sharee Ellis (Data Manager) and have recently welcomed Julie Morgan as our new Admin/Data support). Carol Munt has stepped up into the new position of Data Coordinator. Mary-Ann Hamilton (Nurse Co-ordinator) and Paula Palmer (Data Support) all continue to demonstrate their commitment to the auditing of our breast cancer care/treatment by way of the WBCR. This is also a vital database for future research. On the clinical trials front – Debbie Metcalfe, Shelley Cavanagh and Jenni continue to do a terrific job. Julie Wilson (PA and Team Administrator) took on the chal enging position of Fundraising Co-ordinator last July. Julie has done a fantastic job with increasing sales and distribution of our 2011 diary and has plans to grow the fundraising side of the Trust as above. Julie has designed regular newsletters, upgraded the WBCT brochure and instigated a new tag line for the Trust which is now incorporated into our logo. Julie has also updated the website to include ecommerce facilities to make donating online and buying merchandise easier. Julie also secured major sponsorship from Braemar Hospital ($10,000 + GST for 5 years) for the WBCT Pink Walk. ATTENDANCE AT MEETINGS AND CONFERENCES Trust staff have attended the following international meeting/s. These were; The Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting “Cancer and Beyond” 8-11 November, 2010: Melbourne, Australia. Held jointly with the Australian New Zealand Breast Cancer Trials Group Annual Scientific Meeting Jenni Scarlet and Debbie Metcalfe attended this conference with support from the Gallagher Group, and the Waikato Bay of Plenty Division of the Cancer Society. Conference highlights included sessions on management of women who carry the breast cancer gene mutations, survivorship issues, and updates on research introducing new surgery, chemotherapy and radiotherapy techniques. There were interesting updates on multiple research projects to enable greater understanding of what happens at the level of different cells (e.g. stem, mammary) in our body and also research contributing to a better understanding of the complexity of cancer cells. There is exciting early stem cell research being carried out in Australia investigating whether a human can grow another breast as a possible future alternative to breast reconstruction.
There were interesting sessions on IT and cancer care. A David Roder (Consultant Epidemiologist for Cancer Australia) presented on cancer registries in Australia highlighting the importance of registries as an intelligent resource for complex decision making. Australia is further ahead than NZ with the collection of cancer information. David’s presentation reiterated the multi faceted importance of our Waikato (and other NZ) breast cancer registers. I presented at the COSA Trainees session, convened and presented at the SNAC2 Trialists update meeting, and in the ANZBCTG’s scientific session. Australasian Society of Breast Diseases Conference 8-10 July, 2010 – Auckland. This was attended by Carol Munt, Mary-Ann Hamilton, Sharee Ellis, Paula Palmer and myself. Conference attendance was supported by the Waikato DHB, the Grassroots Trust and the WBCT. This was an excellent multidisciplinary meeting covering breast cancer from screening and diagnosis through to treatment. It was evident, from much of the work presented, that long-term comprehensive data collection provides a vital resource for many areas of research. The Waikato Breast Care Register strives to be just such a resource and it was very motivating to see the potential benefits of our everyday work against the wider perspective of international research. In addition to attending the meeting, staff also took advantage of the opportunity to meet with colleagues who conduct the Auckland and Christchurch Breast Cancer Registers. I chaired a session and made 2 presentations. PERSONAL ACKNOWLEDGEMENTS Thank you to all our Trustees – Debbie Gisby, Raewyn Sporle, Clive Cleland and Michael Jameson for the donation of your time, energy and considerable expertise. In October, 2010 we farewelled Tony Hope after over 7 years of dedicated support and work. Thank you Tony for your exceptional contribution during this time. In October last year we welcomed Margaret Comer as a Trustee. We really appreciate Margaret’s/the Gallagher Group’s already substantial support of the WBCT. Thanks go to Graham Brown & Co Ltd for their pro bono accounting services, in particular thanks to Shannon Double, Rachel Bassett, Amy Gittings and Tinnika Begbie for their valued assistance with the WBCT accounts.
Thank you also to our dedicated research staff underwritten by the once again outstanding contribution of our secretary, Jenni Scarlet. The level of support from all of you continues to establish Waikato as a leading centre for breast cancer research in New Zealand with ongoing benefits for women in our region and beyond.
Secretary’s Note As with previous years Ian has continued over the 2010-11 year to be an active member of the ANZ Breast Cancer Trials Group Scientific Advisory Committee and NZ Representative on the Board of Directors. He is on the Steering Committee for the Zo-Fast and LATER trials. Other committee roles include; 1) Chairperson, NZ Guidelines for Management of Breast Cancer, NZ Guidelines Group; 2) Chair of the Local Therapy Subcommittee of the ANZBCTG Scientific Advisory Committee; 3) NZ Representative on the Royal Australasian College of Surgeons Breast Section, their Audit and Evidence and Performance Subcommittees; 4) Member of the SNAC Trials Management Committee and Chair of SNAC2; 5) Lead Surgeon for Breast Screen Midland and BSM representative on the BSA Surgeons Unidisciplinary Group; and 6) Chair of Midland Cancer Network, Breast Cancer Work Group. At most national and international meetings and conferences that Ian attends, he is always actively involved in presenting, chairing sessions or involved in running of workshops.
Appendix 1 Research currently administered by the Waikato Breast Cancer Trust includes; A) Studies/Projects currently open for accrual;
Studies further evaluating sentinel node biopsy
SNAC (Sentinel Node biopsy versus Axillary Clearance) trial Part 2. The initial Sentinel Node Biopsy versus Axillary Clearance (SNAC) Part 1 study, (now closed to accrual) aimed to answer the question: “Does sentinel node biopsy (removal of the first lymph nodes related to the breast cancer, only followed by axillary clearance if these nodes contain cancer) result in reduced side effects from surgery compared to standard axillary clearance?”. Part 2 of this research extends the work started in Part 1. This extension evaluates the use of sentinel node biopsy in women with larger breast cancers or with more than one cancer in the breast. Part 2 of the SNAC trial will also contribute to answering the very important question; “Does sentinel node biopsy result in increased local recurrence or decreased survival, and if so, for which group of women is this the case and for whom is axillary clearance really necessary?
Studies evaluating the best management of women at high risk or diagnosed with ductal carcinoma insitu
The International Breast cancer Intervention Study 2 (IBIS 2) evaluates whether the drug anastrozole can prevent breast cancer in women at elevated risk. There is a second part to this study where the use of anastrozole is being compared to tamoxifen for women with hormonally sensitive ductal carcinoma in situ (DCIS). The Waikato is also a centre for the IBIS 2 bone sub-study, available for women participating in the prevention arm. This research evaluates the impact of anastrozole on bone health and whether the drug risedronate can prevent loss of bone density in these women.
Studies improving informed consent. As part of the IBIS 2 and SNAC 2 trials we are evaluating the usefulness of a Decision Aid booklet.
Studies evaluating later use of letrozole i) The LATER (Later adjuvant Aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer) trial addresses the important question of whether additional treatment with an aromatase inhibitor started much later (from years 6-15 after diagnosis), could reduce the risk of breast cancer recurrence in postmenopausal women in these later and continued "at risk" years.
ii) The SOLE (Study Of Letrozole Extension) trial This study is evaluating the role of continuous letrozole versus intermittent letrozole following 4-6 years of previous hormonal therapy for postmenopausal women with hormone-receptor positive and node positive early breast cancer. The principle behind the intermittent use of letrozole is that stopping letrozole for 3 months will permit some oestrogenic stimulation which makes residual disease susceptible to letrozole reintroduction.
B) Studies closed to further accrual with ongoing follow-up; •
A study to test whether the drug Tamoxifen can prevent breast cancer in women at high risk for breast cancer (mostly due to a strong family history of the disease). This United Kingdom based study is called the International Breast cancer Intervention Study (IBIS) 1. Study to be completed July/August , 2011 – long term follow-up to be completed by the ANZBCTG.
The best treatment of a precancerous breast condition called ductal carcinoma insitu (DCIS). This study compares surgery alone with the addition of radiotherapy or Tamoxifen, or both, for the treatment of DCIS.
The menstrual cycle study is co-ordinated through the North Central Cancer Treatment Group (U.S.A) and is evaluating whether timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome – namely, the likelihood of breast cancer recurrence or death. Completed June, 2011 and study to close.
The International Breast Cancer Study Group (IBCSG) Study 10-93 examines whether removal of the armpit lymph nodes is necessary in some older women (60 years and over) diagnosed with early breast cancer. Completed June, 2011 and study to close.
HABITS (Hormone Replacement Therapy After Breast Cancer, Is IT Safe?) trial. The safety of a short course of hormone replacement therapy in women with a previously diagnosed early breast cancer who suffer from bothersome menopausal symptoms such as hot flushes and night sweats.
The Breast International Group (BIG 1-98) study compares Letrozole and Tamoxifen alone or the sequential use of these agents.
A head to head comparison of Letrozole and Anastrozole for postmenopausal women with hormone sensitive and lymph node positive early breast cancer (referred to as the FACE trial).
The “SOFT” (IBCSG 24-02) is be testing the role of ovarian function suppression and the role of exemestane in premenopausal women.
The SNAC (Sentinel Node biopsy versus Axillary Clearance) trial (Part 1) is the initial phase of introducing a less radical surgery to the lymph nodes of the armpit using a technique called sentinel node biopsy. The sentinel nodes are the first lymph nodes most closely related to the breast cancer. This study assesses the morbidity (side effects) of SNB compared with axillary clearance and whether the two treatments give equivalent cancer outcomes
IBCSG Study 23 is a trial which aims to contribute to the question of appropriate management for women who have micrometastases (very tiny/microscopic deposits of cancer spread) found in the sentinel nodes. This research aims to answer the question of whether these women require axillary clearance or is it safe to manage these women without further surgery?
REPUBLIKA E SHQIPËRISË -AUTORITETI I KONKURRENCËS- -KOMISIONI I KONKURRENCES- Nr. 87 Datë 22. 09.2008 Autorizimin e përqendrimit të realizuar nëpërmjet përftimit të kontrollit nga shoqëria Deutsche Telekom AG në shoqërinë Hellenic Telecommunication Organization SA dhe indirekt në shoqërinë AMC SHA Komisioni i Konkurrencës me pjesëmarrjen e : Në
Thank you also to our dedicated research staff underwritten by the once again outstanding contribution of our secretary, Jenni Scarlet. The level of support from all of you continues to establish Waikato as a leading centre for breast cancer research in New Zealand with ongoing benefits for women in our region and beyond.
Secretary’s Note As with previous years Ian has continued over the 2010-11 year to be an active member of the ANZ Breast Cancer Trials Group Scientific Advisory Committee and NZ Representative on the Board of Directors. He is on the Steering Committee for the Zo-Fast and LATER trials. Other committee roles include; 1) Chairperson, NZ Guidelines for Management of Breast Cancer, NZ Guidelines Group; 2) Chair of the Local Therapy Subcommittee of the ANZBCTG Scientific Advisory Committee; 3) NZ Representative on the Royal Australasian College of Surgeons Breast Section, their Audit and Evidence and Performance Subcommittees; 4) Member of the SNAC Trials Management Committee and Chair of SNAC2; 5) Lead Surgeon for Breast Screen Midland and BSM representative on the BSA Surgeons Unidisciplinary Group; and 6) Chair of Midland Cancer Network, Breast Cancer Work Group. At most national and international meetings and conferences that Ian attends, he is always actively involved in presenting, chairing sessions or involved in running of workshops.
Appendix 1 Research currently administered by the Waikato Breast Cancer Trust includes; A) Studies/Projects currently open for accrual;
Studies further evaluating sentinel node biopsy
SNAC (Sentinel Node biopsy versus Axillary Clearance) trial Part 2. The initial Sentinel Node Biopsy versus Axillary Clearance (SNAC) Part 1 study, (now closed to accrual) aimed to answer the question: “Does sentinel node biopsy (removal of the first lymph nodes related to the breast cancer, only followed by axillary clearance if these nodes contain cancer) result in reduced side effects from surgery compared to standard axillary clearance?”. Part 2 of this research extends the work started in Part 1. This extension evaluates the use of sentinel node biopsy in women with larger breast cancers or with more than one cancer in the breast. Part 2 of the SNAC trial will also contribute to answering the very important question; “Does sentinel node biopsy result in increased local recurrence or decreased survival, and if so, for which group of women is this the case and for whom is axillary clearance really necessary?
Studies evaluating the best management of women at high risk or diagnosed with ductal carcinoma insitu
The International Breast cancer Intervention Study 2 (IBIS 2) evaluates whether the drug anastrozole can prevent breast cancer in women at elevated risk. There is a second part to this study where the use of anastrozole is being compared to tamoxifen for women with hormonally sensitive ductal carcinoma in situ (DCIS). The Waikato is also a centre for the IBIS 2 bone sub-study, available for women participating in the prevention arm. This research evaluates the impact of anastrozole on bone health and whether the drug risedronate can prevent loss of bone density in these women.
Studies improving informed consent. As part of the IBIS 2 and SNAC 2 trials we are evaluating the usefulness of a Decision Aid booklet.
Studies evaluating later use of letrozole i) The LATER (Later adjuvant Aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer) trial addresses the important question of whether additional treatment with an aromatase inhibitor started much later (from years 6-15 after diagnosis), could reduce the risk of breast cancer recurrence in postmenopausal women in these later and continued "at risk" years.
ii) The SOLE (Study Of Letrozole Extension) trial This study is evaluating the role of continuous letrozole versus intermittent letrozole following 4-6 years of previous hormonal therapy for postmenopausal women with hormone-receptor positive and node positive early breast cancer. The principle behind the intermittent use of letrozole is that stopping letrozole for 3 months will permit some oestrogenic stimulation which makes residual disease susceptible to letrozole reintroduction.
B) Studies closed to further accrual with ongoing follow-up; •
A study to test whether the drug Tamoxifen can prevent breast cancer in women at high risk for breast cancer (mostly due to a strong family history of the disease). This United Kingdom based study is called the International Breast cancer Intervention Study (IBIS) 1. Study to be completed July/August , 2011 – long term follow-up to be completed by the ANZBCTG.
The best treatment of a precancerous breast condition called ductal carcinoma insitu (DCIS). This study compares surgery alone with the addition of radiotherapy or Tamoxifen, or both, for the treatment of DCIS.
The menstrual cycle study is co-ordinated through the North Central Cancer Treatment Group (U.S.A) and is evaluating whether timing of breast cancer surgery during a woman’s menstrual cycle affects her ultimate outcome – namely, the likelihood of breast cancer recurrence or death. Completed June, 2011 and study to close.
The International Breast Cancer Study Group (IBCSG) Study 10-93 examines whether removal of the armpit lymph nodes is necessary in some older women (60 years and over) diagnosed with early breast cancer. Completed June, 2011 and study to close.
HABITS (Hormone Replacement Therapy After Breast Cancer, Is IT Safe?) trial. The safety of a short course of hormone replacement therapy in women with a previously diagnosed early breast cancer who suffer from bothersome menopausal symptoms such as hot flushes and night sweats.
The Breast International Group (BIG 1-98) study compares Letrozole and Tamoxifen alone or the sequential use of these agents.
A head to head comparison of Letrozole and Anastrozole for postmenopausal women with hormone sensitive and lymph node positive early breast cancer (referred to as the FACE trial).
The “SOFT” (IBCSG 24-02) is be testing the role of ovarian function suppression and the role of exemestane in premenopausal women.
The SNAC (Sentinel Node biopsy versus Axillary Clearance) trial (Part 1) is the initial phase of introducing a less radical surgery to the lymph nodes of the armpit using a technique called sentinel node biopsy. The sentinel nodes are the first lymph nodes most closely related to the breast cancer. This study assesses the morbidity (side effects) of SNB compared with axillary clearance and whether the two treatments give equivalent cancer outcomes
IBCSG Study 23 is a trial which aims to contribute to the question of appropriate management for women who have micrometastases (very tiny/microscopic deposits of cancer spread) found in the sentinel nodes. This research aims to answer the question of whether these women require axillary clearance or is it safe to manage these women without further surgery?